A medicare database analysis of practice patterns in patients with mantle cell lymphoma

Weaver, Jessalyn A.; Peng, Yi; Ji, Yuanyuan; Gilbertson, David T.; Pease, Daniel F.; Morrison, Vicki A.

doi:10.1016/j.jgo.2020.12.013

Cited by 3 publications

(2 citation statements)

References 21 publications

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“…1,2 Apart from high-risk disease characteristics, 3 advanced age, poor performance status, and number of comorbidities exhibit an adverse prognostic impact in patients with MCL. 4,5 Patients treated with systemic chemotherapy and advancing age have an inferior outcome compared with young patients with MCL (age # 65 years). 2 The standard-of-care treatment for elderly patients with MCL is rituximab-based chemoimmunotherapy followed by rituximab maintenance (in some studies), [6][7][8][9] providing a median progression-free survival (PFS) of 3-5 years and an overall response rate (ORR) of about 90% with 40%-50% complete response (CR; except the combination of bendamustine, rituximab, and cytarabine, which induced a CR of 91%).…”

Section: Introductionmentioning

confidence: 99%

Ibrutinib With Rituximab in First-Line Treatment of Older Patients With Mantle Cell Lymphoma

Jain

Zhao

Lee

et al. 2022

JCO

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PURPOSE Most patients with mantle cell lymphoma (MCL) are older. In this study, we investigated the efficacy and safety of a chemotherapy-free combination with ibrutinib and rituximab (IR) in previously untreated older patients with MCL (age ≥ 65 years). METHODS We enrolled 50 patients with MCL in this single-institution, single-arm, phase II clinical trial ( NCT01880567 ). Patients with Ki-67% ≥ 50% and blastoid morphology were excluded. Ibrutinib was administered with rituximab up to 2 years with continuation of ibrutinib alone. The primary objective was to assess the overall response rate and safety of IR. In evaluable samples, whole-exome sequencing and bulk RNA sequencing from baseline tissue samples were performed. RESULTS The median age was 71 years (interquartile range 69-76 years). Sixteen percent of patients had high-risk simplified MCL international prognostic index. The Ki-67% was low (< 30%) in 38 (76%) and moderately high (≥ 30%-50%) in 12 (24%) patients. The best overall response rate was 96% (71% complete response). After a median follow-up of 45 months (interquartile range 24-56 months), 28 (56%) patients came off study for various reasons (including four progression, 21 toxicities, and three miscellaneous reasons). The median progression-free survival and overall survival were not reached, and 3-year survival was 87% and 94%, respectively. None of the patients died on study therapy. Notably, 11 (22%) patients had grade 3 atrial fibrillation. Grade 3-4 myelosuppression was seen in < 5% of patients. Differential overexpression of CCND1, BIRC3, BANK1, SETBP1, AXIN2, and IL2RA was noted in partial responders compared with patients with complete response. CONCLUSION IR combination is effective in older patients with MCL. Baseline evaluation for cardiovascular risks is highly recommended. Randomized trial is needed for definitive conclusions.

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Section: Introductionmentioning

confidence: 99%

Ibrutinib With Rituximab in First-Line Treatment of Older Patients With Mantle Cell Lymphoma

Jain

Zhao

Lee

et al. 2022

JCO

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“…Thus, they are valuable for capturing real-world data such as treatment patterns and outcomes, thereby complementing the evidence obtained from clinical trials. Recently, several studies have investigated the treatment patterns and clinical outcomes in patients with MCL using administrative databases [23][24][25][26]; however, data specifically in the post-ibrutinib setting are still lacking.…”

Section: Introductionmentioning

confidence: 99%

Outcomes for Recurrent Mantle Cell Lymphoma Post-Ibrutinib Therapy: A Retrospective Cohort Study from a Japanese Administrative Database

et al. 2022

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Introduction Treatment options in patients with mantle cell lymphoma (MCL) failing ibrutinib are limited, with no standard therapies defined. This study aimed to investigate real-world treatment patterns and outcomes for patients with MCL following ibrutinib. Methods This study utilized a de-identified hospital-based claims database (Medical Data Vision) in Japan. Eligible patients were adults who were diagnosed with MCL and had received antitumor drugs between December 2010 and July 2020. Patients were followed from the first antitumor drug treatment until the end of available data up to July 2021. Time-to-event analyses utilized the Kaplan–Meier method. Factors for receiving post-ibrutinib therapy were explored with logistic regression analysis. Results Of the 1386 patients who started antitumor drug therapy, 247 patients received and discontinued ibrutinib at any line of therapy. Among them, 137 patients (55.5%) received subsequent therapy. The median age at the end of ibrutinib therapy was 77 (range 42–95), and 44 patients had a dependent activity of daily living (ADL). Factors negatively associated with receiving post-ibrutinib therapy after discontinuation of ibrutinib were age ≥ 75 years (odds ratio [95% CI] 0.46 [0.26–0.80]) and emergency hospital admissions (0.37 [0.17–0.84]). Immediate post-ibrutinib therapy regimens were highly diverse, with BR (bendamustine, rituximab) only prescribed in more than 10% of patients. The median duration of post-ibrutinib therapy was 1.5 months (95% CI 1.07–2.07). The median overall survival from the end of ibrutinib therapy in patients regardless of the receipt of post-ibrutinib therapy ( n = 247), in those who did not receive post-ibrutinib therapy ( n = 110), and in those who received post-ibrutinib therapy ( n = 137) was 5.6 months (95% CI 3.8–8.7), 2.3 months (95% CI 1.2–3.9), and 8.7 months (95% CI 5.6–13.8), respectively. The most common adverse event during post-ibrutinib therapy was infection, with the use of anti-infectives (17%). Conclusions Patients with MCL previously treated with ibrutinib have poor ability to carry out ADL and experience very poor outcomes. New safe, effective therapies are needed. Graphical Abstract Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02258-3.

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Assessing unmet need among elderly Medicare Beneficiaries with Mantle cell lymphoma: an analysis of treatment patterns, survival, healthcare resource utilization, and costs

Squires

Puckett²,

Ryland

et al. 2023

Leukemia & Lymphoma

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A medicare database analysis of practice patterns in patients with mantle cell lymphoma

Cited by 3 publications

References 21 publications

Ibrutinib With Rituximab in First-Line Treatment of Older Patients With Mantle Cell Lymphoma

Ibrutinib With Rituximab in First-Line Treatment of Older Patients With Mantle Cell Lymphoma

Outcomes for Recurrent Mantle Cell Lymphoma Post-Ibrutinib Therapy: A Retrospective Cohort Study from a Japanese Administrative Database

Assessing unmet need among elderly Medicare Beneficiaries with Mantle cell lymphoma: an analysis of treatment patterns, survival, healthcare resource utilization, and costs

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